Roflumilast

Overview

Roflumilast, sold under the brand name Daxas among others, is a medication used for the treatment of chronic obstructive pulmonary disease, plaque psoriasis, seborrheic dermatitis, and atopic dermatitis. It acts as a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE-4). It has anti-inflammatory effects.[1–6] WP

It was approved for medical use in the European Union in 2010, in the United States in 2011, and in Canada in 2017. It is available as a generic medication.[1][7][8][9] WP

Drug class

PDE4 inhibitor WP

From the Wikipedia article's infobox.

Uses, dosage and effects

Medical uses

Roflumilast is indicated for the treatment of severe chronic obstructive pulmonary disease (COPD), plaque psoriasis, seborrheic dermatitis, and atopic dermatitis,[1][2][3][10][11] WP

It is used in the prevention of exacerbations (lung attacks) in severe chronic obstructive pulmonary disease (COPD).[1][7][12][13][14] WP

Risks and side effects

Adverse effects

Common (1–10% incidence) adverse effects include diarrhea, weight loss, nausea, headache, insomnia, decreased appetite, abdominal pain, rhinitis, sinusitis, urinary tract infection, and depression.[1][12–15] WP

Legal status

Legal status

In June 2010, an oral formulation of roflumilast was approved in the European Union for severe COPD associated with chronic bronchitis. In February 2011, it gained FDA approval in the United States for reducing COPD exacerbations.[7][16][17][18] WP

In July 2022, the FDA approved roflumilast cream 0.3% (Zoryve) for the treatment of plaque psoriasis in patients 12 years of age and older. In December 2023, the agency approved a 0.3% topical foam formulation for seborrheic dermatitis in patients aged nine and older, marking the first new mechanism of action for the condition in over two decades. In July 2024, the FDA approved a 0.15% cream formulation as a once-daily treatment for mild to moderate atopic dermatitis in adults and children aged six and older. In May 2025, the 0.3% foam formulation received further approval for plaque psoriasis in adults and adolescents aged 12 and older. Subsequently, in October 2025, the FDA extended approval of a 0.05% cream formulation to include pediatric patients aged two to five with atopic dermatitis.[19–24] WP

Chemistry

Formula

C17H14Cl2F2N2O3 PC

CAS number

162401-32-3 PC

Molar mass (g/mol)

403.2 PC

IUPAC name (computed by PubChem)

3-(cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)benzamide PC

SMILES

C1CC1COC2=C(C=CC(=C2)C(=O)NC3=C(C=NC=C3Cl)Cl)OC(F)F PC

InChIKey

MNDBXUUTURYVHR-UHFFFAOYSA-N PC

PubChem CID

449193

IUPAC name

3-(Cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide WP

Harm reduction information

No harm reduction data is on file for this compound yet. That means no dose, timing or combination data from PsychonautWiki or TripSit. Please don't guess a dose from similar compounds. If you have taken it and feel unwell, contact emergency services or a poison control center.

User reports

Pop culture

No references added yet.

Sources

1. Journal / agency Daliresp- roflumilast tablet. 12 March 2020
2. Journal / agency Zoryve- roflumilast cream. 16 August 2022
3. Journal / agency Zoryve- roflumilast aerosol, foam. 20 December 2023
4. Journal / agency Boswell-Smith V, Spina D. PDE4 inhibitors as potential therapeutic agents in the treatment of COPD-focus on roflumilast. International Journal of Chronic Obstructive Pulmonary Disease. 2007. PMID 18044684 · PMC2695611
5. Journal / agency Herbert C, Hettiaratchi A, Webb DC, Thomas PS, Foster PS, Kumar RK. Suppression of cytokine expression by roflumilast and dexamethasone in a model of chronic asthma. Clinical and Experimental Allergy. May 2008. doi:10.1111/j.1365-2222.2008.02950.x · PMID 18307529
6. Journal / agency Field SK. Roflumilast: an oral, once-daily selective PDE-4 inhibitor for the management of COPD and asthma. Expert Opinion on Investigational Drugs. May 2008. doi:10.1517/13543784.17.5.811 · PMID 18447606
7. Journal / agency Daxas EPAR. 17 September 2018
8. Other Daxas Product information. 20 July 2017
9. Journal / agency 2022 First Generic Drug Approvals. 3 March 2023
10. Other FDA Approves Arcutis' Zoryve (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older. 29 July 2022
11. Other FDA Approves Atopic Dermatitis Label Expansion for Arcutis' Zoryve Cream. 10 July 2024
12. Other Daxas 250 micrograms tablets - Summary of Product Characteristics (SmPC). 11 June 2020
13. Journal / agency Daliresp: EPAR - Product Information. 26 September 2013
14. Other roflumilast (Rx) - Daliresp
15. Journal / agency Spina D. PDE4 inhibitors: current status. British Journal of Pharmacology. October 2008. doi:10.1038/bjp.2008.307 · PMID 18660825 · PMC2567892
16. Other "Nycomed's Anti-Inflammatory Gains Approval in EU for COPD"
17. Journal / agency Drug Approval Package: Daliresp Tablets (roflumilast) NDA #022522. 24 December 1999
18. Journal / agency FDA approves new drug to treat chronic obstructive pulmonary disease. 1 March 2011
19. Other Park, Brian. Zoryve Cream Approved for Plaque Psoriasis. 1 August 2022
20. Other Campbell, Patrick. Roflumilast Topical Foam, 0.3% and Full STRATUM Results, with Andrew Blauvelt, MD, MBA. 6 March 2026
21. Other Giara, Kelsey. FDA Approves Non-Steroidal Roflumilast Cream for Atopic Dermatitis. 23 May 2025
22. Other Ernst, Diana. Zoryve Foam 0.3% Approved for Plaque Psoriasis of the Scalp, Body. 4 June 2025
23. Other Soung, Jennifer. Understanding Roflumilast Foam's FDA Approval for Scalp and Body Psoriasis, with Jennifer Soung, MD. 22 May 2025
24. Other Ernst, Diana. Zoryve Cream 0.05% Approved for Atopic Dermatitis in 2- to 5-Year-Olds. 15 October 2025

Text and values on this page are quoted from Wikipedia (CC BY-SA 4.0), PubChem (public domain). Each value links to the exact revision it came from.